SWOG-9400 Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Previously Untreated Acute Lymphocytic Leukemia

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without bone marrow transplantation in treating patients who have acute lymphocytic leukemia.

Conditions

• Leukemia
• Neutropenia
• Thrombocytopenia

Interventions

DRUG

asparaginase

10,000 units/d IV or IM 15 - 24

DRUG

cyclophosphamide

con: 650 mg/m2 IV 1, 15, 29 maint: 650 mg/m2 IV 1

DRUG

cytarabine

cons: 75 mg/m2/d IV Push 2 - 5, 9 - 12, 6 - 19, 23 - 26

DRUG

daunorubicin hydrochloride

ind: 60 mg/m2 IV 22 and 23

DRUG

dexamethasone

main: 10 mg/m2/day PO 1 - 28

DRUG

doxorubicin hydrochloride

main: 25 mg/m2 IV 1, 8, 15, and 22

DRUG

etoposide

60 mg/kg based on ideal body weight day -3

DRUG

leucovorin calcium

5 mg q 6 hours for 4 doses, PO 1, 3, 8, 11 after each methotrexate if WBC \< 3,000 /μl

DRUG

mercaptopurine

con: 60 mg/m2 PO 1 - 28

DRUG

methotrexate

10 mg/m2 IT or IV, d 2, 9, 16, and 23; Maximum 15 mg/admin

DRUG

prednisone

ind: 60 mg/m2/d PO 1 - 21\*, 22 - 28 Patients will receive full dose through day 8 and then tapered to zero between Day 29 and 42. ind2: 60 mg/m2/d PO through day 42

DRUG

thioguanine

main: 60 mg/m2/day PO 1 - 14

DRUG

vincristine sulfate

ind: 1.4 mg/m2 2 mg max, IV 1, 8, 15, and 22 ind2: 1.4 mg/m2 2 mg max IV 29 and 36 main: 1.5 mg/m2 2 mg max, IV 1, 8, 15, and 22

PROCEDURE

allogeneic bone marrow transplantation

day 0

RADIATION

radiation therapy

day -7 through day -4 total dose of radiation is 1,320 cGy.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Stephen J. Forman, MD · City of Hope Comprehensive Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1995-07-31

Primary Completion

2001-12-31

Completion

2003-12-31

Countries

• United States

Study Locations